FDA 510(k)

OTC 雙效電擊療/電肌肉刺激系統

K 號：K172809 · 2017-10-18

決定日期2017-10-18

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

OTC Combo TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172809. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OTC Combo TENS/EMS System?

OTC Combo TENS/EMS System is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K172809.

When did OTC Combo TENS/EMS System receive FDA 510(k) clearance?

OTC Combo TENS/EMS System received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172809.

Who is the listed applicant for OTC Combo TENS/EMS System?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC Combo TENS/EMS System?

The FDA product code for OTC Combo TENS/EMS System is NUH.

其他以 Well-Life Healthcare Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233054健康生活疼痛緩解（月經加強版）電刺激器；TENS/EMS 內含月經緩解刺激器；健康生活疼痛緩解刺激器；月經加強版刺激器 K222528Well-Life 激發/EMG 探針電極 (型號：SA)，Well-Life 尿失禁激發/EMG 電極探針，Well-Life 探針電極 K220524Well-Life Mini TENS刺激器（WL-23XXC/WL-23XXE系列）K213091健康生活 TENS/EMS/加熱刺激器 K200942健康生活衣著電極（GM系列）K162663WELL LIFE Rx 遥控式 TENS/EMS 刺激器，型號 WR-2603/2603A、WR-2604/2604A 及 WR-2605/2605A

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相關器械（代碼：NUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261131電動肌肉刺激器（AST-105DJ、AST-105EJ、AST-105BJ、AST-105GJ、AST-303J、AST-309J、AST-310J；AST-300Q、AST-300Q-A、AST-500B；AST-500G、AST-500F；AST-500N；AST-500C、AST-500K、AST-500A；AST-300E、AST-500M、AST-500U、AST-500D；AST-500E。）Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 可充電 4 頻道 (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS 裝置（FT-247 系列產品）（FT-247，FT-237）Hivox Biotek, Inc.K253896TENS/EMS 裝置（GUSE01）Globalcare Medical Technology Co., Ltd.K253305電擊療與電肌肉刺激器（TENS 和 Muscle Stimulator）(JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

官方來源

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